drugset / Trial / NCT01690403

Interaction Study to Assess the Pharmacokinetic Interaction of Oral Administration of Rifapentine on ATRIPLA™ in HIV Patients

NCT01690403

Phase 1 Completed 25 enrolled Sanofi
Non-randomizedParallel-groupOpen-labelBasic science

Summary

Primary Objective: \- To evaluate the effect of single and repeated administration of rifapentine given as daily or weekly regimen on steady-state pharmacokinetic parameters of efavirenz, emtricitabine and tenofovir given as a fixed dose combination (ATRIPLA™ ). Secondary Objective: \- To evaluate the safety and tolerability of concomitant administration of rifapentine and ATRIPLA™ given to HIV+ patients

Timeline

Start
2012-12
Primary completion
2014-03
Completion
2014-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Efavirenz Other / unclassified Oral
Subject Rifapentine Small molecule Oral
Subject Tenofovir disoproxil fumarate Small molecule Oral
Subject emtricitabine Other / unclassified Oral

Indications